Pharmacogenetic Testing for Medication Management.

NCT02559193 | Withdrawn DMC

• 1 other identifier: MIDAS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.

Conditions

Medication Management

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.

  90-day period following receipt of PGx test results

Study Arms (1)

No treatment.

Data collection only trial design.

Other: Observational study, data collection only trial.

Interventions

Observational study, data collection only trial. OTHER

Data collection only trial design.

No treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.

You may qualify if:

• Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
• Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
• Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;
• \. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.

You may not qualify if:

• Patient is currently hospitalized;
• Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
• Patient is unable to provide an accurate history due to mental incapacity;
• Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

Sponsors & Collaborators

• First Vitals LLC: lead

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Ernie Lee, CHRS

  First Vitals LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 24, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07